In Q3 of FY'20, Zydus Cadila
launched nine new products in the US including a Day One launch, even as it filed four additional abbreviated new drug applications (ANDAs) with the USFDA taking the cumulative number of ANDA filings to 386. Zydus Cadila also stated that it received eight new product approvals including two tentative approvals from the USFDA during Q3 of FY'20.
During the quarter, the company also launched the oral anti-diabetic agent, Vinglyn (Vildagliptin) and Vinglyn M (Vildagliptin plus Metfonnin) in India, the former being one of the most affordable brands of Vildagliptin for diabetic patients in India.
On the research front, the company filed a new drug application (NDA) of Saroglitazar Mg in Non-alcoholic Steatohepatitis (NASH) with the Drug Controller General of India (DCGI), a first with any regulatory authority across Asia and only the second across the globe for NASH indication.
The company also announced the second phase III DREAM-D trials of Desidustat, an lnvestigational New Drug (IND) targeted at treating anaemia in dialysis-dependent CKD (chronic kidney disease) patients, during Q3 of current fiscal 2019-20.
During the quarter, the Company received regulatory permission to conduct Phase-1 clinical trials for Hepatitis A and Hepatitis E Vaccines. Dossiers were also submitted to the DCGI for the Marketing Authorization of Pentavalent Vaccine, it stated.
Meanwhile, the company recently saw the USFDA conclude inspection of the manufacturing facility of one of its wholly-owned subsidiary Alidac Pharmaceuticals Ltd. The regulator had conducted inspection between January 27 and February 4, 2020 at the site that manufactures oncology injectables for regulated markets, with no observations being issued by USFDA.